2018 was the first year of the tumor immunotherapy in China. The new era of tumor immunotherapy has begun in China with the marketing of anti-PD-(L)1 antibodies represented by Opdivo, Keytruda, and Tuoyi, etc. in China. The development progress of the anti-PD-(L)1 products are analyzed here in this article.

I. China accelerating entry into the era of tumor immunotherapy: 4 anti-PD-(L)1 antibodies approved

BMS’ anti-PD-1 monoclonal antibody: Opdivo was the first of the 4 approved for marketing on June 15, 2018, which is approved to treat EGFR/ALK- patients who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or intolerance to prior platinum-based chemotherapy. China has since entered the era of tumor immunotherapy.

4 anti-PD-1 monoclonal antibodies have so far been approved in China, and 3 anti-PD-(L)1 antibodies are in the marketing review stage.

Wherein:

Among the marketed anti-PD-1 monoclonal antibodies:

1. There are 2 imported drugs and 2 Chinese-produced drugs;

2. 3 indications are covered, separately being NSCLC, melanoma, and Hodgkin’s lymphoma (HL);

3. The review time was about 165-272 days;

4. In terms of price, the annual cost of imported drugs is RMB150,000-200,000, while that of Chinese-produced drugs is lower than RMB100,000 (price after drug donation/assistance).

Opdivo assistance program:

See the Assistance Program of Opdivo Patient Assistance Project of Cancer Foundation of China

http://www.cfchina.org.cn/show.php?contentid=1717

Keytruda assistance program:

MSD has conducted the charitable aid activity for malignant melanoma patients in association with China Primary Health Care Foundation (CPHCF). See the following for the details

http://smzy.ilvzhou.com

Tuoyi assistance program:

Every Step of the Way—Bethune Tuoyi Public Donation Project: see the following for the details

http://www.bjbqejjh.org.cn/news-detail.asp?id=1202

II. The "Pacific storm" of AstraZeneca to arrive: Durvalumab applied for marketing

In addition to the 4 anti-PD-(L)1 monoclonal antibodies marketed, many other anti-PD-(L)1 monoclonal antibodies are expected to be approved for marketing in China in 2019.

There are still 3 antibodies under marketing review in China at present:

1. 2 Chinese-produced pharmaceutical products, and 1 imported pharmaceutical product;

2. The indications are HL and stage III NSCLC;

3. The review cycle of Hengrui Medicine’s camrelizumab is longer than similar products.

Among the 3 drugs under marketing review:

1. The indication applied for Hengrui Medicine’s camrelizumab is HL. According to the 2018 financial report of Hengrui medicine, accumulatively RMB397 million has been invested in the relevant project, the progress of the indications of liver cancer and esophagus cancer has been smooth, and the company, one of the medical product suppliers, has set up a sales team for the marketing of the product. The review time of the drug has exceeded that of similar products, however, in my opinion, camrelizumab is still likely to be approved for marketing, which is expected to be at the end of Mar. 2019.

2. With regard to AstraZeneca’s durvalumab, according to its financial report, the indication applied therefor is unresectable stage III NSCLC without disease progression after chemotherapy, and the approval of this big indication has greatly driven the global market performance of durvalumab. Durvalumab will continue to add luster to AstraZeneca’s performance in China after it enters China through the indication of stage III NSCLC.

China has Entered the Era of Tumor Immunotherapy.

Keep Reading:

7 anti-PD-(L)1 antibodies in Phase III clinical trials: lung cancer is still an important indication competed for

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